The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by the House last month, as reported here. The President immediately signed it into law.
As we previously reported, the Biosimilar User Fee Act “BsUFA II” portion of the FDA Reauthorization Act of 2017 creates important changes for biosimilar applicants, including new user fees and application timelines. In particular, the bill would increase user fees from $508 million to $1.3 billion in 2018 and extend the application review timeline by two months, while empowering the FDA to collect $9 billion in user fees between 2018 and 2022. More complete details on the changes to the legislative authority can be found in our previous post here.